人参再造丸中3种双酯型生物碱的限量检查方法研究  

Study on the Limit Detection Method for Three Diester Alkaloids in Renshen Zaizao Pills

作　　者：黄晓燕 李靖云 谭智艳 孙辉 丁野 李文莉 HUANG Xiaoyan;LI Jingyun;TAN Zhiyan;SUN Hui;DING Ye;LI Wenli(Hunan Institute of Drug Inspection and Testing,Hunan Engineering and Technology Research Center for Pharmaceutical Quality Evaluation,Changsha Hunan 410001,China;Chenzhou Food and Drug Inspection and Testing Center,Chenzhou Hunan 423000,China.)

机构地区：[1]湖南省药品检验检测研究院,湖南省药品质量评价工程技术研究中心,湖南长沙410001 [2]郴州市食品药品检验检测中心,湖南郴州423000

出　　处：《药品评价》2024年第5期536-539,共4页Drug Evaluation

摘　　要：目的建立人参再造丸中双酯型生物碱的限量检查方法。方法采用超高效液相色谱-质谱联用法(UPLC-MS/MS)对人参再造丸中双酯型生物碱(新乌头碱、次乌头碱、乌头碱)的含量进行测定,流动相为乙腈-0.1%甲酸溶液,进行梯度洗脱,电喷雾离子源,正离子模式下采用多反应监测模式测定。结果3种双酯型生物碱均有较好的线性关系,在精密度、稳定性、重复性试验中RSD均低于5%,平均回收率和RSD分别为96.14%~100.38%和1.59%~2.86%。结论所建立的方法能同时准确、快速地测定人参再造丸中3种双酯型生物碱成分的含量,专属性强、重复性好,可为全面、有效地控制人参再造丸的质量提供参考。Objective To establish a limit detection method for three types of diester alkaloids in renshen zaizao pills.Methods The content of diester alkaloids(mesaconitine,hypaconitine,aconitine)in renshen zaizao pills was determined by UPLC-MS/MS,with acetonitrile and 0.1%formic acid solution as mobile phase,gradient elution,electrospray ion source,and multi reaction monitoring mode under positive ion mode.Results The linear relationship of the three types of diester alkaloids was good,and the RSD for precision,stability,and repeatability tests were all less than 5%.The average recovery rate and RSD were 96.14%to 100.38%and 1.59%to 2.86%,respectively.Conclusion The established method can accurately and quickly determine the content of three diester type alkaloids in renshen zaizao pills,with strong specificity and good repeatability.It can provide reference for the comprehensive and effective control of the quality of renshen zaizao pills.

关 键 词：人参再造丸 新乌头碱 次乌头碱 乌头碱 双酯型生物碱 超高效液相色谱-质谱 

分 类 号：R286.0[医药卫生—中药学]